Hong Kong Baptist Hospital (HKBH) reckons clinical research is pivotal to the practice of evidence-based medicine and is an important relevance in improving clinical care. In relation to research involving human participants, the Hospital has an obligation to ensure research is designed and conducted in accordance with the International Conference on Harmonization - Good Clinical Practice Guidelines (ICH-GCP Guidelines) and ethically reviewed and monitored in accordance with the Declaration of Helsinki.

Hong Kong Baptist Hospital established the Clinical and Research Ethics Committee (CREC) in 2008. The CREC have become a fundamental and essential infrastructure responsible for governing clinical research ethics and safeguarding the rights, safety and wellbeing of human subjects.

1.

Formulate and revise hospital policy and guidelines on clinical ethics

2.

Ethical review of research protocols and the conduct of research for identifying potential safety concerns for staff and researchers

3.

Protect the mental and physical welfare, rights, dignity and safety of participants of research involving humans, their data or human tissue

4.

Monitor and evaluate the progress of approval projects to ensure that they fall within the guidelines provided

5.

Facilitate ethical research through efficient and effective review processes

6.

Provide advice on the medical-ethical issues

7.

Enhance the ethical environment for health care professionals

8.

Provide medical ethics education program

It is the responsibility of the CREC of Hong Kong Baptist Hospital to:

1.

Provide advice on the ethical aspects of their research proposals and projects in safeguarding the rights, safety and welfare of human subjects

2.

Grant, withhold or withdraw approval for research proposals in accordance with ethical standards and guidelines

3.

Monitor the approved research through review of research progress report, final report, and serious adverse event (SAE) report

4.

Terminate or suspend approved projects if they are not conducted in accordance with ethical standards and guidelines

5.

Provide advice on the medical ethics issues

Members of CREC are selected from a wide variety of medical and non-medical fields within the hospital and community. The composition of the CREC will include at least the following personnel:

A Chairman

At least two members who have no affiliation with the Hospital

At least one member who performs a pastoral care role

At least two members with knowledge of, and current experience in the professional care or treatment of patient

At least one member with experience in quality assurance

The CREC is independent and impartial. A CREC's opinion must be free, and must be seen to be free, from conflicts of interest. All the information disclosed to a CREC member will be deemed confidential and shall not be disclosed to any third party or used for any purpose other than performing the responsibilities of a CREC member. Members are appointed by the Director of Medical Services (CREC Chairman) and required to undertake:

Maintain the confidentiality

Declare any conflicts of interest that exist or may arise

All research studies require formal approval in the form of a favorable ethical opinion from the CREC. Ethical consideration is given to all research studies (clinical or non-clinical) which involve the collection of data from HKBH patients and staff. Ethical approval is not required for non-research activities such as, clinical audit, service/ practice evaluation and surveillance projects.